Digital Health Legal

Volume: 2 Issue: 8
(August 2015)


Turkey’s Social Security Institution (‘SSI’) published a set of institutional guidelines relating to the use, sharing and protection of SSI health data on 23 July, which was the result of a board of directors’ resolution held on 9 July. The new guidelines allow for the sharing and sale of citizens’ health insurance data held by the SSI. / read more

Portugal published on 27 July Law 73/2015, which amends the Clinical Investigation Law 21/2014 and principally allows access to clinical trial data, including participants’ records, for trial investigators and a newly created role of ‘auditors,’ in addition to trial monitors. The auditors and investigators’ role is to ensure trials are in accordance with European Medical Agency rules. / read more

The US National Institute of Standards and Technology (‘NIST’) released through its cyber security centre on 23 July ‘Securing Electronic Health Records on Mobile Devices,’ guidance dedicated to helping IT staff protect medical records when these are accessed or transferred across smartphones and tablets. / read more


Patient care is becoming increasingly fragmented between different domains and organisations, as care becomes more complex. ‘Open APIs’ are being welcomed as a possible saviour of health IT in the UK, a way to open up the market to innovation and to free patient data from their current silos in pursuit of more integrated care. The aim is welcomed but successful delivery is complex. Matt Murphy, Managing Director of EMIS Health, a supplier of electronic patient record systems and software, describes how quality assurance and safeguards are essential to protect critical health systems, and that suppliers must be allowed to influence the process. / read more

eHealth products and services have the potential to produce false or inaccurate readings; in the worse case these could lead to actual harm to patients, creating a plethora of questions around product liability and jurisdictional issues. For example, if a health app provides inaccurate information that is relied upon by a patient in another country than the app developer’s home country, and the user later makes a claim for compensation, in what jurisdiction would the patient sue? Andrew Austin, Michael Ramb, Ian Jones and Richard Bird of Freshfields Bruckhaus Deringer examine these product liability and jurisdictional issues. / read more

With the rise in the popularity of electronic signatures companies conducting clinical trials have begun to look to e-signatures as a means to verify a trial subject’s informed consent. The question remains however as to whether an electronic signature can fulfil the necessary criteria of the signature being both ‘written’ and ‘signed.’ Robert Bond and Alexia Zuber of Charles Russell Speechlys LLP discuss the legal challenge for using electronic signatures in clinical trials. / read more

While technology companies have found it relatively easy to partner with healthcare incumbents such as retail pharmacies to take part in the digital health revolution in the US, it has been more of a challenge for big pharma companies to enter this space. Yet examples have emerged of pharma and tech companies partnering; for example ingestible sensor technology provider Proteus Digital Health has spent five years working with pharma companies. Stephen Graham, Partner at Fenwick & West, explores what has so far limited pharma companies’ involvement in the digital health space and what the future holds for partnering ‘beyond the pill.’ / read more

Alexis Gilroy, Cristiana Spontoni, Katherine Llewellyn and Undine von Diemar of Jones Day in this article review the regulatory situation for telemedicine and data protection in the EU and US, and the challenges arising for telemedicine providers in both jurisdictions. / read more

Recently, Italian regulators have undertaken initiatives to administer efficient and effective healthcare by developing electronic networks and expanding the computerised management of records, documents, and processes. To contribute to this, the Italian Data Protection Authority (‘DPA’), the Garante, published a new set of guidelines in Italy’s Official Gazette on 17 July on electronic patient records, aimed at providing greater protection for patient data. Silvia Stefanelli of Stefanelli & Stefanelli Law Firm and Amandeep Gargi, Strategy Consultant at the Chinese Dental Cooperation, an Italian start-up, provide detailed analysis of the new guidelines. / read more

About Digital Health Legal:

Digital Health Legal is the monthly publication covering legal and regulatory issues and providing industry perspectives in the health IT sector. The publication covers eHealth, mHealth apps, data protection and privacy, electronic patient records, health data security and data breaches, telehealth and telemedicine, medical devices, online pharmacies, social media, standardisation, pharmacovigilance, patient safety, Big Data, health care informatics, cloud services in healthcare, liability, IP rights and HIPAA... /read more

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